Morning MEDtalks with Dr K K Aggarwal

Morning Health Talk:

New Delhi, July 22, 2018:

Valsartan Update

DCGI has enhanced checking of the Chinese bulk drug Valsartan at the ports after the American regulatory agency recalled Valsartan early this week over potential cancer risks.

The Drugs Controller General of India instructed the ports to examine each and every batch of the imported consignment of a Chinese bulk drug named Valsartan API, manufactured by Zhejiang Huahai Pharmaceuticals.

Earlier this week US FDA recalled Valsartan over potential cancer risk due to the presence of an impurity – a chemical known as NDMA or N-nitrosodimethylamine. Later European Medical Agency too issued an alert. So far, more than 20 countries recalled this Chinese API.

Oxytocin Ban Deferred for Two Months

The government had banned the import of oxytocin formulations and restricted its manufacture to the public sector only from July 1 earlier. “The ban has now been deferred by two months, as decided by the Health Ministry.” – S Eswara Reddy, Drug Controller General India (DCGI)

The government has to put on hold by two months its decision to restrict the manufacturing and supply of oxytocin only through the Karnataka Antibiotics and Pharmaceuticals Ltd (KAPL). Accordingly, this ban is likely to come into effect from 1st September 2018.

Karnataka Antibiotics & Pharmaceutical Ltd (KAPL), a public sector unit (PSU), is the only manufacturer for the drug in the country. KAPL will be the sole supplier to registered hospitals and clinics in both public and private sector. The same order prohibits the retail sale of the oxytocin by chemists and druggists.

Registered hospitals and clinics in public and private sector in the country are advised to contact KAPL to place their orders with the company at MD KAPL

Source: Dr. Dinesh Baswal

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Dr KK Aggarwal
Padma Shri Awardee
Vice President CMAAO
President HCFI